HIV Infections, Tuberculosis
Conditions
Keywords
TB, Tuberculosis, INH, Isoniazid, Preventive therapy, HIV, AIDS, Botswana, LTBI, Latent TB Infection
Brief summary
This is a randomized, blinded, two-arm comparative trial of continued versus limited isoniazid (INH) tuberculosis (TB) preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.
Detailed description
Randomized, double blinded, two-arm comparative trial of continuous vs. limited isoniazid preventive therapy in HIV-infected adults in Gaborone and Francistown, Botswana. Subjects will be accrued over two years and followed for a minimum of 36 months.
Interventions
DRUGIsoniazid
Daily 300 mg isoniazid supplemented with 25 mg pyridoxine for 6 months vs 36 months.
Sponsors
Centers for Disease Control and Prevention
Botswana Ministry of Health
United States Agency for International Development (USAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV-infected 2. Age \>=18 years 3. Tuberculin skin test positive or negative 4. Laboratory: * Hemoglobin (Hgb) \>6.5 gm/dl; * Neutrophil count \>1,000 cells/mm3; * Platelets \>75,000/mm3; * AST (SGOT) \<122 U/L; * Creatinine \<1.5 mg/dl; * Beta HCG = negative 5. Karnofsky performance status \>=60 6. Signed informed consent
Exclusion criteria
1. History of TB in the last 3 years or current active TB 2. History of noncompliance to chronic therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incident Tuberculosis | During follow-up (36 months) | Incident tuberculosis during follow-up. Tuberculosis cases were categorized as: Definite: ≥1 positive culture for M. tuberculosis or ≥2 sputum smears positive for acid-fast bacilli; Probable: 1 sputum smear or biopsy specimen positive for acid-fast bacilli; Possible: clinical diagnosis with negative or unavailable smear/culture results. Outcome data include definite, probable, and possible tuberculosis cases combined, consistent with the published analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Died | During follow-up (36 months) | All-cause mortality during the 36-month follow-up period. |
| Tuberculosis and Death Composite Outcome | During follow-up (36 months) | Composite of incident tuberculosis and all deaths during the 36-month follow-up period. The paper presents this as "Tuberculosis and all deaths." |
Countries
Botswana
Contacts
PRINCIPAL_INVESTIGATORTaraz Samandari, MD, PHD
Centers for Disease Control and Prevention
Participant flow
Pre-assignment details
The planned sample size was 2000 participants; however, 1995 participants were ultimately enrolled and randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1995 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 989 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Botswana | 989 Participants |
| Sex: Female, Male Female | 1436 Participants |
| Sex: Female, Male Male | 291 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 39 / 1,006 | 38 / 989 |
| other Total, other adverse events | 0 / 1,006 | 0 / 989 |
| serious Total, serious adverse events | 9 / 1,006 | 6 / 989 |
Outcome results
None listed